FDA Adverse Event
Injury
Summary report: N
SM PLUS SBT/OVAL BALLOON DISSECTOR
MDR report key: 2572867
·
Received May 3, 2012
Report
- Report Number
- 2647580-2012-00310
- Event Type
- Injury
- Date Received
- May 3, 2012
- Date of Event
- March 26, 2012
- Report Date
- April 2, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K042412
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE SURGEON WAS PERFORMING A REPAIR AND ATTEMPTED TO UTILIZE THE DEVICE TWICE WITH SAME INCIDENT HAPPENING WITH EACH USE. SALES REP WAS PRESENT AT THE TIME OF DEVICES MALFUNCTIONING. NO HARM NOTED TO PATIENT WITH SLIGHT DELAY, FIRST SPACEMAKER USED WAS INFLATED. THE SURGEON TRIED TO TAKE OUT #2 FROM #3 AND CANNULA/BALLOON GOT STUCK AND BALLOON BROKE. COULDN'T GET CAMERA THROUGH TROCAR, HAD TO TAKE OUT #1 AND 32 AND ONLY USE #3 (TROCAR). LOT 3P1L0911.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM PLUS SBT/OVAL BALLOON DISSECTOR | BALLOON PORT | GCJ | COVIDIEN, FORMERLY USSC PUERTO RICO | P1L0911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |